Determine if atomoxetine is safe and well tolerated by children with FAS. [ Time Frame: length of protocol ] [ Designated as safety issue: Yes ]

Determine if atomoxetine is effective in both school and home, and significantly reduces symptoms of inattention, hyperactivity, and impulsivity in children with FAS compared to children with FAS receiving placebo. [ Time Frame: length of protocol ] [ Designated as safety issue: No ]

Determine if atomoxetine improves behaviors in the mornings and evenings. [ Time Frame: Length of protocol ] [ Designated as safety issue: No ]

Determine if parents of children with FAS are satisfied with the effectiveness of atomoxetine. [ Time Frame: Length of protocol ] [ Designated as safety issue: No ]

Determine if there are any differences in the adverse effects profile of children with FAS compared to the overall profile for atomoxetine. [ Time Frame: Length of protocol ] [ Designated as safety issue: Yes ]

Determine the degree of functional limitation experienced by this group of children with FAS and whether this impairment is decreased by treatment with atomoxetine as demonstrated by the Pediatric Evaluation of Disability Inventory (PEDI) [ Time Frame: Length of protocol ] [ Designated as safety issue: No ]

Abnormalities of attention, function, and activity level in children exposed to alcohol in utero share similarities and differences to children who do not have alcohol exposure. Previous psychological studies have examined either core attention deficit hyperactivity disorder (ADHD)symptoms of hyperactivity, inattention, and impulsivity or hypothesized neuropsychological differences in children with fetal alcohol syndrome (FAS) and ADHD. Atomoxetine Hydrochloride is a non-stimulant medication used to treat ADHD. This study will determine if atomoxetine HCL significantly reduces symptoms of ADD/ADHD in children with fetal alcohol exposure.

Eligibility

Ages Eligible for Study:

4 Years to 11 Years (Child)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient must be between the ages of 4 and 11 years at the time of entry into the study.

Patients must meet diagnostic criteria for FASD

Patient must meet DSM-IV criteria for ADHD, any subtype and must have an ADHDRS-IV score of > or = to 90%ile for age and gender for either subtest or total score if greater than 5 years of age.

Patients who enter the study at visit 1 taking stimulant medication must be medication-free for at least 24 hours before visit 2.

History and physical exam must reveal no clinically significant abnormalities that would preclude safe participation in the study.

Patients must be able to swallow capsules.

Patients must be of a sufficient developmental level (~3 yrs) to participate in the study.

Patients and parents must be able to communicate effectively with the investigator and coordinator and be judged reliable to keep appointments and participate in data collection.

Teacher must agree to cooperate with the study. Children less than 6 years old must have completed a course of PCIT and still meet DSM-IV criteria for ADHD.

Exclusion Criteria:

Have received an in investigational medication in the past 30 days.

Are currently on a medication treatment that is effective (ADHDRS-IV score within 1 SD of average) and well tolerated.

Have significant current medical conditions that could be exacerbated or compromised by atomoxetine.

Have used MAOIs within one month prior to visit 2.

Patients with hypertension.

Patients with a previous diagnosis of bipolar disorder, psychosis, or autism spectrum disorder.

Patients taking anticonvulsants for seizure control.

Patients taking another psychotropic medication or health food supplements purported to have central nervous system activity within 5 half-lives of visit 2.

Patients with Tourette Disorder or any other neurological condition that would interfere with their ability to receive treatment or comply with monitoring.

Pubertal girls.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417794